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Coltene/Whaledent Inc.

United States·US-MF-000015761

Last updated September 17, 2026

What Coltene/Whaledent Inc. makes

Coltene/Whaledent Inc. manufactures reusable dental instruments, including carbide burs, rotary and reciprocating endodontic files, abrasive points, and rubber dam clamps. Their portfolio also includes resin artificial teeth, root canal posts, and ultrasonic scaling/debridement systems, as well as latex-based rubber dams for isolation during dental procedures.

The company’s devices are classified under FDA’s Class I and Class II categories and are listed in the FDA’s Unique Device Identifier (UDI) database. The manufacturer operates from the United States.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Frequently asked questions

What types of medical devices does Coltene/Whaledent Inc. primarily manufacture?

Coltene/Whaledent Inc. specializes in reusable dental instruments and materials. Their portfolio includes carbide dental burs, rotary and reciprocating endodontic files, abrasive points, rubber dam clamps, resin artificial teeth, root canal posts, and ultrasonic scaling/debridement systems. These devices are designed for use in dental procedures, such as cavity preparation, root canal treatment, tooth isolation, and scaling.

Where is Coltene/Whaledent Inc. based, and does that location impact their device regulations?

Coltene/Whaledent Inc. is based in the United States. Since the company operates within the U.S., its devices are subject to FDA regulations. The FDA classifies their products as either Class I or Class II, depending on the risk level and intended use, which determines the regulatory pathway for authorization.

Are Coltene/Whaledent Inc.’s devices listed in any regulatory registries, and why does this matter?

Yes, Coltene/Whaledent Inc.’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This matters because the UDI system ensures traceability, transparency, and better tracking of medical devices in the supply chain. It helps healthcare providers, regulators, and manufacturers identify and monitor devices throughout their lifecycle, reducing risks like counterfeiting or recall issues.

How are Coltene/Whaledent Inc.’s devices classified by the FDA, and what does that classification mean?

Coltene/Whaledent Inc.’s devices are classified under FDA’s Class I and Class II categories. Class I devices generally pose minimal risk and may require general controls (e.g., labeling, manufacturing practices) for authorization. Class II devices involve a higher risk and may require additional controls, such as performance standards or post-market surveillance, to ensure safety and effectiveness before they can be used in clinical settings.

What does it mean for a device to be listed in the FDA’s UDI database, and how does it relate to Coltene/Whaledent Inc.’s products?

Listing in the FDA’s UDI database means the device has been assigned a unique identifier, combining a device identifier and a production identifier. This helps distinguish Coltene/Whaledent Inc.’s products—such as their carbide burs, endodontic files, or ultrasonic scaling systems—from other similar devices in the market. The UDI system improves patient safety, streamlines recalls, and enhances supply chain efficiency by providing clear, standardized information about each device’s specifications and batch details.

AI-generated from registry data and not verified by a human reviewer.

Information

Country: United States
Address: 235, Ascot Parkway, Cuyahoga Falls, United States
Website: www.coltene.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +1 330 916 8800
PRRC Contact: Tricia Cregger
EUDAMED SRN: US-MF-000015761
FDA FEI Number: 2416455
DUNS Number: —

Catalogue (3196)

Page 60 of 64

Device	Model / Reference	Registries	Class	Status
HYGENIC Wax Sticks, Scented, 48 pcs	H00826	EUDAMEDFDA UDI	Class I	Active
TMS Bulk Kit, Regular Gold, Gold-Plated Stainless Steel, 2in1, 2 x 100 pcs	T09	EUDAMEDFDA UDI	Class IIa	Active
3 ParaPost Drills - Size 7	P427	EUDAMEDFDA UDI	Class IIa	Active
UC150 Replacement Lid	60022045	EUDAMEDFDA UDI	Class I	Active
6 Kodex Twist Drills Minim Silver, without Depth-Limitation	K93	EUDAMEDFDA UDI	Class IIa	Active
10 ParaPost Threaded Short Posts - Stainless Steel, 1.75mm	PDTA7	EUDAMED	Class IIa	Active
20 ParaPost XP Titanium Temporary Posts (.070" / 1.75mm)	P7467	EUDAMEDFDA UDI	Class IIa	Active
ParaPost Starter Drill and Universal Hand Driver	TEDC1	EUDAMED	Class IIa	Active
10 ParaPost XT Titanium Posts (.040" / 1.00mm)	P6840	EUDAMEDFDA UDI	Class IIa	Active
Ultrasonic Scaler Insert #10 (30kHz) – SuperSoft	USG1030K	EUDAMEDFDA UDI	Class IIa	Active
10 ParaPost Titanium Posts (.045" / 1.14mm)	P8445	EUDAMEDFDA UDI	Class IIa	Active
25 ParaPost Stainless Steel Posts (.050" / 1.25mm)	P445B	EUDAMEDFDA UDI	Class IIa	Active
25 ParaPost Stainless Steel Posts (.055" / 1.40mm)	P4455B	EUDAMEDFDA UDI	Class IIa	Active
TMS LINK PLUS Bulk Kit, Regular Gold, Gold-Plated Stainless Steel, 2in1, 50 pcs	L752	EUDAMEDFDA UDI	Class IIa	Active
25 ParaPost XP Stainless Steel Posts (.045" / 1.14mm)	P74445B	EUDAMEDFDA UDI	Class IIa	Active
SPEC 3 Light Shield, 11mm	60014360	EUDAMEDFDA UDI	Class I	Active
6 Kodex Twist Drills Regular Gold, Depth-Limiting	K96	EUDAMEDFDA UDI	Class IIa	Active
3 ParaPost TaperLux Drills - Size 5.5	P8255	EUDAMEDFDA UDI	Class IIa	Active
ParaPost XT - One-Office-Visit Introductory Kit - Titanium	P680T	EUDAMEDFDA UDI	Class IIa	Active
PerFect TCS 45º Long Loop Electrode Sheaths, 2 pcs	S6015A	EUDAMEDFDA UDI	Class IIb	Active
3 ParaPost TaperLux Drills - Size 5	P825	EUDAMEDFDA UDI	Class IIa	Active
10 Parapost Plus Stainless Steel Posts (.036" / 0.90mm)	P2443	EUDAMEDFDA UDI	Class IIa	Active
10 ParaPost XP Titanium Posts (.040" / 1.00mm)	P7844	EUDAMEDFDA UDI	Class IIa	Active
ParaPost Threaded Short - One-Office-Visit Introductory Kit - Stainless Steel	PDM	EUDAMED	Class IIa	Active
6 Kodex Twist Drills Minuta Pink	K89	EUDAMEDFDA UDI	Class IIa	Active
10 ParaPost Plus Titanium Posts (.060" / 1.50mm)	P2846	EUDAMEDFDA UDI	Class IIa	Active
10 ParaPost XP Stainless Steel Posts (.036" / 0.90mm)	P7443	EUDAMEDFDA UDI	Class IIa	Active
10 ParaPost Threaded Short Posts - Stainless Steel, 0.90mm	PDTA3	EUDAMED	Class IIa	Active
PRESIDENT Impression Trays - Upper Left/Lower Right- Quadrant - Size 7	C6907	EUDAMEDFDA UDI	Class I	Active
10 ParaPost XT Titanium Posts (.060" / 1.50mm)	P6860	EUDAMEDFDA UDI	Class IIa	Active
10 ParaPost XH Titanium Posts (.055" / 1.40mm)	P8855	EUDAMEDFDA UDI	Class IIa	Active
6 Kodex Twist Drills Minikin Red, Long Shank	K91	EUDAMEDFDA UDI	Class IIa	Active
TMS LINK SERIES Complete-Kit, Minikin Red, Titanium Alloy, 20 pcs	L811	EUDAMEDFDA UDI	Class IIa	Active
PerFect TCS Handpiece Holder	S7001	EUDAMEDFDA UDI	Class IIb	Active
Accu-Trac 576 Accu-Trac Precision Die Trays, Super Economy Pack	ATT576	EUDAMED	Class I	Active
3 ParaPost XT Drills - Size 5.5	P6255	EUDAMEDFDA UDI	Class IIa	Active
HYGENIC Boxing Wax, Regular, 450 g	H00815	EUDAMEDFDA UDI	Class I	Active
10 ParaPost Threaded Short Posts - Stainless Steel, 1.50mm	PDL6	EUDAMED	Class IIa	Active
Coltolux LED Charger Base w/ Power Supply, Domestic Units	C7970RK1	EUDAMEDFDA UDI	Class I	Active
3 TENAX Drills 1.5mm	TEA15	EUDAMED	Class IIa	Active
20 ParaPost XP Titanium Temporary Posts (.050" / 1.25mm)	P7465	EUDAMEDFDA UDI	Class IIa	Active
Pindex System 100 Pindex Replacement Blades - 0.007	PX301	EUDAMEDFDA UDI	Class I	Active
10 ParaPost Plus Stainless Steel Posts (.055" / 1.40mm)	P24455	EUDAMEDFDA UDI	Class IIa	Active
TMS Refill, Minim Silver, Gold-Plated Stainless Steel, 2in1, 2 x 50 pcs	T11	EUDAMEDFDA UDI	Class IIa	Active
HYGENIC Bite-Wafers, Double, 24 pcs	H04030	EUDAMEDFDA UDI	Class I	Active
3 TENAX Fiber Trans Drills 1.3mm	TED13	EUDAMED	Class IIa	Active
5 ParaPost Fiber White Posts (.060" / 1.50mm)	PF1616	EUDAMEDFDA UDI	Class IIa	Active
3 ParaPost Drills - Size 4.5	P4245	EUDAMEDFDA UDI	Class IIa	Active
UC150 Cassette Basket	60022040	EUDAMEDFDA UDI	Class I	Active
TMS Complete-Kit, Minikin Red, Gold-Plated Stainless Steel, 20 pcs	T107	EUDAMEDFDA UDI	Class IIa	Active

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FDA Recalls (14)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Coltene/Whaledent Inc. has 14 recall records initiated between December 11, 2013, and January 20, 2023, with statuses recorded as open, classified, or terminated. The reasons cited include mispackaging—such as latex dental dams shipped in non-latex packaging, incorrect bur labeling (FG 557 mislabeled as FG 57), and wrong-sized dental posts or pins—and labeling errors, including incorrect product numbers. One record notes a potential mechanical issue with a turbine head connection that may loosen during use, while others involve deviations in product dimensions affecting compatibility with dental tools.

AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.

Date	Recall No.	Class	Status	Reason
Jan 20, 2023	Z-1208-2023	—	open, classified	Screw connection between the turbine head and the push button may loosen and fall off during the treatment, and increase the risk of swallowing or inhaling part of the turbines head or the push button
Mar 18, 2021	Z-1494-2021	—	open, classified	The incorrect dental pins were packaged and subsequently distributed.
Oct 20, 2020	Z-0464-2021	—	open, classified	The FG 557 bur was incorrectly packaged as the FG 57 bur. The FG 557 burs will remove more material than the FG 57 burs.
Oct 20, 2020	Z-0465-2021	—	open, classified	The FG 557 bur was incorrectly packaged as the FG 57 bur. The FG 557 burs will remove more material than the FG 57 burs.
Oct 20, 2020	Z-0468-2021	—	open, classified	The FG 557 bur was incorrectly packaged as the FG 57 bur. The FG 557 burs will remove more material than the FG 57 burs.
Oct 20, 2020	Z-0466-2021	—	open, classified	The FG 557 bur was incorrectly packaged as the FG 57 bur. The FG 557 burs will remove more material than the FG 57 burs.
Oct 20, 2020	Z-0467-2021	—	open, classified	The FG 557 bur was incorrectly packaged as the FG 57 bur. The FG 557 burs will remove more material than the FG 57 burs.
Jun 3, 2020	Z-2420-2020	—	open, classified	Multiple Coltene batches of the product have a pin size larger than acceptable, which may make it difficult for the forceps to fit appropriately with dental dam clamps.
Jun 3, 2020	Z-2419-2020	—	open, classified	Multiple Coltene batches of the product have a pin size larger than acceptable, which may make it difficult for the forceps to fit appropriately with dental dam clamps.
Jun 3, 2020	Z-2422-2020	—	open, classified	Multiple Coltene batches of the product have a pin size larger than acceptable, which may make it difficult for the forceps to fit appropriately with dental dam clamps.
Jun 3, 2020	Z-2421-2020	—	open, classified	Multiple Coltene batches of the product have a pin size larger than acceptable, which may make it difficult for the forceps to fit appropriately with dental dam clamps.
Aug 21, 2018	Z-0376-2019	—	terminated	ParaPost Plus Titanium Posts contain stainless steel post that are a size 4
Apr 13, 2018	Z-1883-2018	—	terminated	The products are labeled with an incorrect product number.
Dec 11, 2013	Z-2151-2014	—	terminated	Coltne/Whaledent Inc. received a complaint about the dental dams being the incorrect color. During an internal investigation, the firm found that Latex dental dams had been packaged in Non-Latex packaging.

FDA Establishments (2)

Establishments registered with the FDA under this company group, matched by name.

Coltene/Whaledent Ag ALTSTAETTEN Sankt Gallen · CH FEI 3002806620
Coltene/Whaledent Gmbh & Co. Kg LANGENAU Baden-Wurttemberg · DE FEI 3001180585